Critical IllnessPhase 1/2POWERNCT04058977
Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness
A Phase 1/2 study testing Power training in people with Critical Illness and Muscle Atrophy or Weakness, run by Kirby Mayer at 1 site in United States.
Trial summary
Patients surviving critical illness experience significant skeletal muscle dysfunction and weakness. Muscle atrophy suffered during critical illness has a long-term impact on the functionality and mobility of these individuals. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Critical Illness, Muscle Atrophy or Weakness
- What is being tested?
- Power training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2021to Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to medicine ICU
- acute respiratory failure or ARDS
- sepsis
- anticipated >48 hours MV
Who cannot join
- acute neurologic infarct
- non-ambulatory prior to hospitalization
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness: A Randomized Controlled Trial
Patients surviving critical illness experience significant skeletal muscle dysfunction and weakness. Muscle atrophy suffered during critical illness has a long-term impact on the functionality and mobility of these individuals. As a result, individuals surviving critical illness have a significant reduction in quality of life, even up to 5 years post discharge. Research including large randomized controls demonstrates that rehabilitation focused on active mobilization may positively influence patient outcomes. Thus, early mobilization is an important intervention that has many purported benefits. Current rehabilitation practice in the intensive care unit (ICU) and recommendations from clinical practice guidelines such as the Society of Critical Care Medicine, PADIS Guidelines support these interventions to reduce the detrimental effects of immobilization during critical illness. Early mobilization is routinely thought of as standard of care for patients admitted for acute respiratory distress syndrome and sepsis. However, a significant number of recent randomized controlled trials implementing early rehabilitation and mobilization interventions fail to demonstrate immediate or long-term benefits.10,11,18,19 Interesting, active mobilization and rehabilitation analyzed in systematic review had no impact on mortality and "no consistent effects of function, quality of life and ICU or hospital length of stay."18 There are a few potential explanations for interventions not leading to reduction in impairment or functional benefit.
Scientific Premise: From our preliminary data (Figure 1) and my clinical experience, a significant cause of the physical impairments in these patients is reductions in muscular power. Muscular power is a critical determinant of functional mobility.20 Preliminary data demonstrate that lower extremity muscle power is significantly reduced in this population and furthermore, these deficits are strongly correlated to physical function. Muscle power training is a potential therapeutic intervention that could lead to more robust improvements in physical function. This concept has been explored extensively in community-dwelling older adults. A recent systematic review of controlled trials demonstrates that power training is superior to traditional resistance training at improving functional performance when comparing the two training modalities.21 Furthermore, power training is feasible for older adults and clinical populations of Parkinson's Disease, Stroke, and frailty.22-27 Thus the feasibility and pragmatic nature of power training is not a concern. Of interest, a randomized controlled trial was completed in institutionalized frail nonagenarians (>85 years or older).27 In this study, no patients drop-out of study due to power training and significant benefits in function were achieved.27 Therefore, the investigators propose a interventional trial to study the effect of a standardized muscle power training program for patients admitted to the ICU for critical illness.
- Conditions
- Critical Illness, Muscle Atrophy or Weakness
- Being tested
- Power training
- Medical subject headings
- Critical Illness, Muscular Atrophy, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power trainingOther
Progressive exercise protocol with focus on velocity of movement
| Study group | Role | What they receive |
|---|---|---|
| Power training | Experimental | Randomized to early power training with standardized exercise progression plus standard of care Receives: Other: Power training |
| Standard of Care | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Performance Physical Battery
This outcome measure is scored from 0-12 with lower scores representing disability and higher scores representing better physical function. This test has three components including balance, chair rise time, and habitual gait speed. There is a pre-defined scoring system with participants scoring 0-4 on each test, higher representing better function.
These individual components can then be further analysed based on continuous variables of five repetitions of chair rise and habitual 4-meter gait speed. Faster times to complete the the chair-rise test and faster gait speed represents better physical function.
Measured: 6-month follow-up
Secondary outcomes (2)
Quality of life: Eq-5D
The Eq-5d is a validate quality of life questionnaire that the participant completes. It has five components each on a scale from 1 to 5, which higher scores representing poor or worse quality of life. A total score can be assessed out of possible 25.
Measured: 6-month follow-up
Six minute walk test (6-mwt)
The 6-mwt is a test of physical function and strength in which participant walks as far as possible in six-minutes. Final distance is analysed as a continuous variable with higher distances being better.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study startDec 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Withdrawn prior to participant enrollment due to funding status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Mayer
- Sponsor type
- University, hospital or other
- Collaborators
- Nathan Johnson, PT, PhD, Ashley Montgomery-Yates, MD, Amy Pastva, PT, PhD, Peter E. Morris, MD
- Responsible party
- Sponsor-investigator, Kirby Mayer, University of Kentucky
- Investigators
- Kirby P Mayer, DPT, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058977
- Sponsor's protocol ID
- 46072
- Acronym
- POWER
- Status last verified
- Oct 2020
- First submitted
- 14 Aug 2019
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following completion of the proposed experiments, data sharing will be accomplished in a timely fashion via dissemination through publications in peer-reviewed journals and through presentations at national and international meetings.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redefining Survivorship: POWER to Maximize Physical Function for Survivors of Critical Illness: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04058977
- Acronym / sponsor ID
- POWER / 46072
- Conditions
- Critical Illness, Muscle Atrophy or Weakness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn prior to participant enrollment due to funding status
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kirby MayerUniversity, hospital or other
- Collaborators
- Nathan Johnson, PT, PhD, Ashley Montgomery-Yates, MD, Amy Pastva, PT, PhD, Peter E. Morris, MD
- Study start
- Dec 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients surviving critical illness experience significant skeletal muscle dysfunction and weakness. Muscle atrophy suffered during critical illness has a long-term impact on the functionality and mobility of these individuals. As a result, individuals surviving critical illness have a significant reduction in quality of life, even up to 5 years post discharge. Research including large randomized controls demonstrates that rehabilitation focused on active mobilization may positively influence patient outcomes. Thus, early mobilization is an important intervention that has many purported benefits. Current rehabilitation practice in the intensive care unit (ICU) and recommendations from clinical practice guidelines such as the Society of Critical Care Medicine, PADIS Guidelines support these interventions to reduce the detrimental effects of immobilization during critical illness. Early mobilization is routinely thought of as standard of care for patients admitted for acute respiratory distress syndrome and sepsis. However, a significant number of recent randomized controlled trials implementing early rehabilitation and mobilization interventions fail to demonstrate immediate or long-term benefits.10,11,18,19 Interesting, active mobilization and rehabilitation analyzed in systematic review had no impact on mortality and "no consistent effects of function, quality of life and ICU or hospital length of stay."18 There are a few potential explanations for interventions not leading to reduction in impairment or functional benefit.
Scientific Premise: From our preliminary data (Figure 1) and my clinical experience, a significant cause of the physical impairments in these patients is reductions in muscular power. Muscular power is a critical determinant of functional mobility.20 Preliminary data demonstrate that lower extremity muscle power is significantly reduced in this population and furthermore, these deficits are strongly correlated to physical function. Muscle power training is a potential therapeutic intervention that could lead to more robust improvements in physical function. This concept has been explored extensively in community-dwelling older adults. A recent systematic review of controlled trials demonstrates that power training is superior to traditional resistance training at improving functional performance when comparing the two training modalities.21 Furthermore, power training is feasible for older adults and clinical populations of Parkinson's Disease, Stroke, and frailty.22-27 Thus the feasibility and pragmatic nature of power training is not a concern. Of interest, a randomized controlled trial was completed in institutionalized frail nonagenarians (>85 years or older).27 In this study, no patients drop-out of study due to power training and significant benefits in function were achieved.27 Therefore, the investigators propose a interventional trial to study the effect of a standardized muscle power training program for patients admitted to the ICU for critical illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Power training | Experimental | Other: Power trainingRandomized to early power training with standardized exercise progression plus standard of care |
| Standard of Care | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admitted to medicine ICU
- acute respiratory failure or ARDS
- sepsis
- anticipated >48 hours MV
Key exclusion criteria (3 listed)
- acute neurologic infarct
- non-ambulatory prior to hospitalization
- pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power trainingProgressive exercise protocol with focus on velocity of movement | Other | Power training |
Primary outcome
Short Performance Physical Battery
Time frame: 6-month follow-up
This outcome measure is scored from 0-12 with lower scores representing disability and higher scores representing better physical function. This test has three components including balance, chair rise time, and habitual gait speed. There is a pre-defined scoring system with participants scoring 0-4 on each test, higher representing better function. These individual components can then be further analysed based on continuous variables of five repetitions of chair rise and habitual 4-meter gait speed. Faster times to complete the the chair-rise test and faster gait speed represents better physical function.
2 secondary outcomes
Quality of life: Eq-5D
Time frame: 6-month follow-up
Six minute walk test (6-mwt)
Time frame: 6-month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: Yes. Following completion of the proposed experiments, data sharing will be accomplished in a timely fashion via dissemination through publications in peer-reviewed journals and through presentations at national and international meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirby P Mayer, DPT principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Power training in people with Critical Illness and Muscle Atrophy or Weakness, run by Kirby Mayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Performance Physical Battery (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.